December19, 2018

Klobuchar and Grassley’s Preserve Access to Affordable Generics and Biosimilars Act would increase consumer access to affordable drugs by extending their prior legislation against harmful pay-for-delay deals to cover biosimilars, as well as generic drugs

WASHINGTON- U.S. Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, and Senator Chuck Grassley (R-IA), Chairman of the Senate Judiciary Committee, are introducing new bipartisan legislation to limit anticompetitive pay-for-delay deals that prevent or delay the introduction of affordable follow-on versions of branded pharmaceuticals. The bill extends the reach of their prior legislation – the Preserve Access to Affordable Generics Act – to cover pay-for-delay deals affecting biosimilar and interchangeable biologics, in addition to the generic drugs already covered under the prior bill. Biologics are a fast-growing class of medicines that are more expensive than traditional pharmaceutical products. The use of “pay for delay” deals—the practice in which drug companies usepay-off agreements to delay the introduction of cheaper substitutes – could make some critical prescriptions unaffordable for patients and impose significant costs on our healthcare system.

“Biologics play an important and growing role in treating many serious illnesses. Without competition, U.S. patients will likely see additional price increases on biologics in the years to come,” said Klobuchar. “This legislation will spur competition to drive down prices, helping to ensure patients can access the medications they need to improve their quality of life.”

“When brand-name drug makers and generics manufacturers enter into agreements to keep more affordable medicines out of the marketplace, all of us are left to pay the price,” said Grassley. “Competition is critical to keep prescription drug prices low. Generics and biosimilar drugs are critical to treating a variety of serious illnesses. Our bill will curb the anti-competitive, pay-for-delay tactics that artificially inflate prices for patients.”

Klobuchar and Grassley have long supported efforts to combat anti-competitive tactics in the pharmaceutical market. The senators are the lead sponsors of the Preserve Access to Affordable Generics Act, which would limit “pay for delay” deals in which brand-name and generic drug manufacturers use anti-competitive pay-off agreements to delay cheaper generic equivalents from reaching consumers. Earlier this Congress, Grassley and Klobuchar also introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would address abuses and delay tactics that prevent generic companies from performing the necessary testing and distribution necessary for U.S. Food and Drug Administration (FDA) approval. The CREATES Act passed the Senate Judiciary Committee on June 14, 2018 on a strong, bipartisan vote of 16 to 5. The Congressional Budget Office (CBO) has estimated that the bill would result in almost $4 billion in savings.

Klobuchar has championed efforts to protect consumers and lower prescription drug costs by promoting competition in the healthcare system, authoring multiple pieces of bipartisan legislation that would address the high cost of prescription drugs. Klobuchar introduced legislation—that has 34 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 41 million seniors enrolled in Medicare Part D. Last year, Klobuchar and the late Senator John McCain (R-AZ) introduced the Safe and Affordable Drugs from Canada Act, bipartisan legislation that would allow individuals to safely import prescription drugs from Canada. Klobuchar’s Short on Competition Act, introduced with Senator Mike Lee (R-UT), would allow the temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the U.S.

In November 2018, Klobuchar and Senator Chuck Grassley (R-IA), sent a letter to the sent a letter to the President urging him to support legislation to limit anticompetitive “pay-for-delay” pharmaceutical settlements as part of the Administration’s effort to bring down the skyrocketing price of prescription drugs. Full text of the letter can be found here.

In a June 2018 letter, Klobuchar and Grassley urged the Federal Trade Commission (FTC) to examine whether makers of biologic medicines are using strategies like “pay for delay” to hinder or delay biosimilars from entering the market. Full text of the letter can be found here.